FDA Approves Ancient Anti-Inflammatory Drug for Heart Disease

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Colchicine, used as an anti-inflammatory and gout remedy for thousands of years, has now been approved by the U.S. Food and Drug Administration (FDA) to reduce inflammation in the cardiovascular system that leads to heart attacks and strokes.

The FDA approved colchicine (Lodoco) for use by adults with atherosclerosis, a thickening and hardening of the arteries caused by plaque buildup inside blood vessels, the drug’s developer Agepha Pharma, said in a statement. The drug was also approved for adults with multiple risk factors for cardiovascular disease.

These high-risk patients typically take statins to lower their risk of experiencing or dying from heart disease events like heart attacks and strokes. Combination therapy with statins and colchicine can reduce the risk of dying from heart disease or having nonfatal heart attacks or strokes by 31 percent compared with a placebo, the company said.

“With colchicine, we now for the first time have access to an anti-inflammatory agent that actually works, decreasing the risk of cardiovascular events, and that is also very safe to use and affordable,” says Guillaume Marquis-Gravel, MD, an interventional cardiologist at Montreal Heart Institute and an assistant professor at the University of Montreal.

“This is a real breakthrough,” adds Dr. Marquis-Gravel, who has no financial ties to Agepha Pharma.

Inflammation Contributes Significantly to Heart Attack and Stroke Risk

Scientists have known for decades that inflammation plays a major role in the development of atherosclerosis and its clinical consequences, including heart attacks and strokes, Marquis-Gravel says. But medicines tested specifically to fight cardiovascular inflammation haven’t panned out because they were either ineffective or came with dangerous side effects.

The FDA cleared 0.5 milligram once-daily Lodoco pills to be taken alone or in combination with cholesterol-lowering drugs like statins to attack inflammation in the cardiovascular system that leads to atherosclerosis, heart attacks, and strokes. Colchicine was first approved by the FDA more than a decade ago as a gout treatment and is also approved for familial Mediterranean fever, an inflammatory disease that causes acute pain in the abdomen, chest, and joints.

Colchicine Has Been Used for Centuries to Treat Inflammation

Centuries earlier, colchicine was used as a poison in ancient Rome and as remedy for joint pain and other inflammatory conditions in ancient Egypt, per the Royal College of Physicians of Edinburgh. Research notes that it’s derived from the Colchicum autumnale plant, also known as autumn crocus.

“Colchicine is a very old drug, comes from mother nature, and was until now used for gout attacks,” says Jan Hein Cornel, MD, PhD, a professor of cardiology at Radboud University Medical Center in Alkmaar, the Netherlands, who has no financial ties to Agepha Pharma.

It makes sense that this ancient treatment would help prevent heart attacks and strokes because inflammation plays a role in plaques eroding or rupturing inside arteries damaged by atherosclerosis, Dr. Cornel adds. Plaques that break loose can travel through blood vessels and cut off the supply of blood to the heart or brain, causing heart attacks or strokes.

“This means a tremendous step forward in the field of prevention of atherosclerotic cardiovascular disease,” Cornel says.

Agepha Pharma said Lodoco will go on sale in the second half of 2023, and didn’t indicate how much the medicine would cost.

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